A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer
NCT ID: NCT06202261
Last Updated: 2024-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
154 participants
INTERVENTIONAL
2023-04-13
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TQB2930 for injection
TQB2930 for injection,10 mg/kg, quaque week (QW), 21 day as a treatment cycle; TQB2930 for injection, 20 mg/kg, quaque 2 weeks (Q2W), 28 day as a treatment cycle; TQB2930 for injection,30 mg/kg, quaque 3 weeks (Q3W), 21 day as a treatment cycle.
TQB2930 for injection
TQB2930 for injection is a HER2 bispecific antibody.
TQB2930 for injection 30mg/kg + Paclitaxel for injection (albumin-bound)
TQB2930 for injection 30mg/kg combined with paclitaxel (albumin-bound) for injection, 21 days for one treatment cycle
TQB2930 for injection
TQB2930 for injection is a HER2 bispecific antibody.
Paclitaxel for injection (albumin-bound)
It is an anti-microtubule chemotherapy drug
TQB2930 for injection+TQB3616 capsule for injection + fulvestrant injection
TQB2930 for injection 20mg/kg combined with TQB3616 capsule 120mg or 150mg or 180mg, and fulvestrant injection. Q2W, 28 days a cycle.
TQB2930 for injection
TQB2930 for injection is a HER2 bispecific antibody.
TQB3616 capsule
TQB3616 capsule is a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor.
Fulvestrant injection
Fulvestrant is a competitive estrogen receptor antagonist with similar affinity to estradiol
TQB2930 for injection + chemotherapy
TQB2930 for injection 30mg/kg combined with capecitabine tablets or vinorelbine tartrate injection or eribulin mesylate injection or gemcitabine hydrochloride for injection, 21 days a cycle.
TQB2930 for injection
TQB2930 for injection is a HER2 bispecific antibody.
Capecitabine tablets
Capecitabine is converted to 5-fluorouracil (5-FU) by in vivo enzyme action.
Vinorelbine tartrate injection
Vinorelbine is an anti-tumor drug of vinca alkaloids.
Eribulin mesylate injection
Eribulin induces G2/M phase cell cycle arrest, mitotic spindle division, and ultimately apoptosis after prolonged mitotic arrest through its tubulin-based anti-mitotic mechanism.
gemcitabine hydrochloride for injection
Gemcitabine is a cell cycle specific anti-metabolic anticancer agent
Interventions
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TQB2930 for injection
TQB2930 for injection is a HER2 bispecific antibody.
Paclitaxel for injection (albumin-bound)
It is an anti-microtubule chemotherapy drug
TQB3616 capsule
TQB3616 capsule is a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor.
Fulvestrant injection
Fulvestrant is a competitive estrogen receptor antagonist with similar affinity to estradiol
Capecitabine tablets
Capecitabine is converted to 5-fluorouracil (5-FU) by in vivo enzyme action.
Vinorelbine tartrate injection
Vinorelbine is an anti-tumor drug of vinca alkaloids.
Eribulin mesylate injection
Eribulin induces G2/M phase cell cycle arrest, mitotic spindle division, and ultimately apoptosis after prolonged mitotic arrest through its tubulin-based anti-mitotic mechanism.
gemcitabine hydrochloride for injection
Gemcitabine is a cell cycle specific anti-metabolic anticancer agent
Eligibility Criteria
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Inclusion Criteria
* Phase Ib
1. Advanced malignancies confirmed by cytology / histopathology, priority given to subjects with HER2 expression or amplification;
2. Subjects with malignant tumors who have failed standard treatment or lack effective treatment;
3. Confirmed presence of at least one evaluable lesion according to RECIST 1.1 criteria
* Phase II
1. Hormone receptor (HR)-negative, HER2-positive breast cancer confirmed by cytology / histopathology, with evidence of local recurrence or distant metastasis, unsuitable for surgery or radiotherapy for curative purposes:
2. Have not received systemic antitumor therapy for metastatic stage; Systemic use of endocrine therapy is permitted, but not exceed 2 lines;
3. at least one measurable lesion that meets the RECIST 1.1 criteria.
* Major organs are functioning normally.
* Female subjects of reproductive age should agree to use contraceptive methods during the study period and until 6 months after the end of the study; Negative serum pregnancy / urine pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects; Male subjects should agree to use contraception during the study and until six months after the end of the study.
Exclusion Criteria
* Unalleviated toxicity above Common Terminology Criteria for Adverse Events (CTCAE) grade 1 due to any prior treatment;
* Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the first dose;
* Long-term unhealed wounds or fractures;
* Arterial/venous thrombosis events occurred within 6 months before the first dose;
* Have a history of psychotropic drug abuse and can't get rid of it or have mental disorders;
* Subject with any severe and/or uncontrolled disease;
* Subjects who have been treated with other antitumor agents such as chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first dose, within 5 half-lives of the drug;
* Have used traditional chinese medicine with anti-tumor indications approved by National Medical Products Administration (NMPA) within 2 weeks before the first dose;
* Severe bone injury due to bone metastasis;
* Subjects with untreated active brain metastases or meningeal metastases or cancerous meningitis;
* In the course of previous HER2-targeted therapy, Left Ventricular Ejection Fractions (LVEF) decreased to \<50% or absolute LVEF decreased \>15%;
* Cumulative doses of anthracyclines exceeded doxorubicin or doxorubicin liposomes \>360 mg/m2;
* Uncontrolled hypercalcemia or symptomatic hypercalcemia requires continued bisphosphonate therapy
* Patients with severe hypersensitivity after the use of monoclonal antibodies;
* Has participated in other antitumor clinical trials within 4 weeks prior to the first dose.
18 Years
75 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Affiliated Cancer Hospital of Chongqing University
Chongqing, Chongqing Municipality, China
Affiliated cancer hospital of harbin medical university
Harbin, Heilongjiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TQB2930-Ib/II-01
Identifier Type: -
Identifier Source: org_study_id
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